Umbralisib

Unassigned

New Medicines

Relapsed or refractory marginal zone lymphoma and follicular lymphoma

Information

New molecular entity
TG Therapeutics
TG Therapeutics

Development and Regulatory status

Phase II Clinical Trials
Phase II Clinical Trials
Pre-registration (Filed)
Yes
Jun 20 · Also has orphan drug status in US for FL [5].
Jun 20 · Filed in US for relapsed or refractory MZL and follicular lymphoma. The FDA has previously granted breakthrough therapy designation for the treatment of adult patients with marginal zone lymphoma, who have received at least one prior anti-CD20 regimen [4,5].
Mar 20 · US FDA grants Orphan Drug Designation to umbralisib for the treatment of follicular lymphoma (FL) [3].
Nov 19 · PIIb trial results announced [1].

Category

PI3K delta inhibitor
Follicular lymphoma is usually not considered to be curable, and is a chronic disease. Patients can live for many years with this form of lymphoma [1]. Incidence in Europe is 3.8/100,000, though this varies with age and location [2].
Relapsed or refractory marginal zone lymphoma and follicular lymphoma
Intravenous

Trial or other data

Jun 20 · PIIb trial UNITY-NHL met the primary endpoint of overall response rate (ORR, prespecified as 40-50%) as determined by Independent Review Committee (IRC) for all treated patients in the MZL cohort (n=69) who had received at least one prior line of therapy with an anti-CD20 monoclonal antibody [2].
Nov 19 · PIIb UNITY-NHL trial met the primary endpoint of overall response rate (ORR, prespecified as 40-50%) as determined by Independent Review Committee (IRC) for all treated patients in the follicular lymphoma cohort (n=118) who have received at least two prior lines of therapy including an anti-CD20 monoclonal antibody and an alkylating agent [1].